Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGIV-C · 3 trials · 3 indications
Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.
To measure improvement in MG symptoms by the mean change in QMG total score from Baseline (Week 0) to Week 24 as compared to placebo. Evaluators score 13 individual items (range from 0=best to 3=worst) and the individual scores are added together for the total score (range 0-39). An average 3-point improvement in QMG score indicates clinically meaningful improvement.
The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. Subjects who discontinued the study early with adverse outcomes related to MG were considered as not achieving a 50% or greater reduction. The missing dose reduction at Week 39 was imputed using the worst observation carried forward (WOCF) method. For subjects who did not have CS dose prescribed at Week 39 due to other reasons, the last observation carried forward (LOCF) method was used to impute the prescribed CS dose at Week 39. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The percent of subjects achieving ≥50% reduction in CS dose from baseline to Week 39 is presented for each treatment group overall and for the baseline daily prednisone equivalent dose level stratification categories.
| Arm | Type | Description |
|---|---|---|
| IGIV-C Treatment | EXPERIMENTAL | In this arm, subjects with myasthenia gravis exacerbations were treated with an IV dose of 2 g/kg of IGIV-C, which was administered over 2 consecutive days at a dose of 1 g/kg per day. |
| IGIV-C | EXPERIMENTAL | IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified. An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8). |
| Placebo | PLACEBO_COMPARATOR | Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8). |
| Name | Type | Description |
|---|---|---|
| IGIV-C | BIOLOGICAL | An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day. |
| Placebo | DRUG | - |
Inclusion Criteria: * Was male or female aged ≥18 years. * Subjects must be willing and able to provide written informed consent (if applicable, a legally authorized representative may provide informed consent on behalf of the subject). * Subjects who met the clinical criteria for diagnosis of MG w...
IGIV-C is an investigational intravenous immunoglobulin product being studied for use in myasthenia gravis, including generalized myasthenia gravis and myasthenia gravis exacerbations, as well as primary immunodeficiency. It is being developed by Grifols, S.A. (GRFS) and is currently in clinical trials.
IGIV-C is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the efficacy and safety of IGIV-C in patients with myasthenia gravis and primary immunodeficiency.
IGIV-C is in Phase 2 clinical development for generalized myasthenia gravis and myasthenia gravis. It has also been studied in Phase 3 trials for myasthenia gravis exacerbations and primary immunodeficiency. All trials listed for IGIV-C have been completed.
IGIV-C has been studied in several completed clinical trials, including NCT02413580 for myasthenia gravis exacerbations, NCT02473952 for generalized myasthenia gravis, NCT02473965 for corticosteroid dependent myasthenia gravis, and NCT02604810 for primary immunodeficiency. These trials were randomized, double-blind, and placebo-controlled.
IGIV-C is not the same as IGSC 20%. IGIV-C is an intravenous immunoglobulin product, while IGSC 20% is a subcutaneous immunoglobulin product. Both are being studied by Grifols for different conditions, with IGIV-C evaluated in myasthenia gravis and IGSC 20% evaluated in primary immunodeficiency.